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Completed

NCT Number: NCT04227158

The Association Between the Distributions MCH and RBC, and Mortality in Hemodialysis Patients

Patients were classified into two groups based on the values of MCH and RBC, patients with MCH ≥30 pg but <35 pg and RBC ≤350×104/μL; and MCH <30 pg and RBC >350×104/μL. Associations between all-cause mortality and the distributions of MCH and RBC were assessed by Kaplan-Meier curves and Cox proportional hazards regression model.

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Key information

Conditions

Renal Anemia

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Graduate School of Applied Informatics, University of Hyogo

Kobe, Hyōgo, 650-0047, Japan

About this study

The Hb levels generally provides the value of RBC and iron status because mean corpuscular hemoglobin MCH is derived from the Hb divided by RBC. MCH depends on the size and concentration of erythrocytes. Thus, the value of RBC and MCH depend on dose of ESA and iron, respectively. Guidelines for Renal Anemia in Chronic Kidney Disease of 2015 Japanese Society for Dialysis Therapy recommend administration hemoglobin (Hb) levels ≥10 g/dL but <12 g/dL in dialysis patients.Patients whose Hb levels is maintained at 10 to 12 g/dL, Hb levels is widely distributed when divided into RBC and MCH. Therefore, the investigators examined the prognosis of life in the distribution of MCH and RBC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be controlled with hemoglobin levels between ≥10 g/dL and <12 g/dL and had undergone maintenance HD for >1 year.

Exclusion criteria

  • Patients will be excluded if they have peritoneal dialysis combined with HD, do not have records of laboratory investigations during this period, or are transferred to another hospital or lost to follow-up.

Treatment and study plan

Primary outcomes

  1. Survival rate between high or low RBC group (all cause death)

    Time frame: three years (retrospectively)

    Survival curves for 3-year survival, based on all available follow-up data, will perform with the use of Kaplan-Meier estimates and will be compared between groups with the use of the log-rank test, and used Holm's method as post hoc.

Sponsors and collaborators

Lead sponsor

University of Hyogo

Other

Registry information

Official study title

The Association Between the Distributions MCH and RBC, and Mortality in a Cohort of Chronic Hemodialysis Patients: a 3-year Retrospective Observational Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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